Article
Incidence Rates of Skin Cancers During Exposure to Intravenous and Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: Results from Pooled Clinical Trial Data
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Authors
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T. Simon
- Bristol-Myers Squibb, Hopewell, United States
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C. Poncet
- DOCS International, Nanterre, France
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M. C. Hochberg
- University of Maryland, Baltimore, United States of America
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M. Boers
- VU University Medical Center, Amsterdam, Netherlands
| Published: | September 1, 2015 |
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Outline
Text
Introduction: TNF inhibitors may increase melanoma risk in patients with RA [1]. In light of that possible association, we investigated the incidence rates (IRs) of skin cancer in IV and SC abatacept using pooled clinical trial data with 16,671 patient-years of exposure.
Methods: Data were pooled from the cumulative (double-blind and open-label short-term [ST] and open-label long-term extension [LTE]) periods of 13 clinical studies: one Phase II and four Phase III trials with SC abatacept [2], and two Phase II and six Phase III trials with IV abatacept [3]. IRs and annualized IRs were calculated, and IRs for the cumulative period were compared with IRs originally estimated from the pooled ST periods.
Results: Overall, 6028 patients received abatacept during the cumulative period (IV: 4149; SC: 1879 patients), with abatacept exposure of 16,671 patient-years (IV: 12,132; SC: 4215 patient-years). Median (range) exposure was 31 (2–104) months; 1167 (19.4%) patients received abatacept for >5 years. In the pooled ST periods of the eight IV abatacept trials, median (range) exposure was 11.7 (1.9–13.8) months.3 During the ST period, there were 19 cases of non-melanoma skin cancer (NMSC) (IR: 0.82/100 patient-years; 95% CI: 0.49, 1.28) in the IV abatacept group and 7 (IR: 0.82/100 patient-years; 95% CI: 0.33, 1.70) in the placebo group. In the ST period, there were zero cases of melanoma in the IV abatacept group and one (IR: 0.12/100 patient-years; 95% CI: 0.00, 0.65) in the placebo group. During the ST+LTE period, 111 patients (IV+SC abatacept) had NMSC (IR: 0.69/100 patient-years; 95% CI: 0.57, 0.83) and 7 had melanomas (IR: 0.04/100 patient-years; 95% CI: 0.02, 0.09). The risk of NMSC and melanoma did not increase over time with increasing exposure to abatacept (Table 1 [Tab. 1]).
Conclusion: Based on cumulative trial data, including nearly 17,000 total patient-years and >30 months of average individual exposure, skin cancer IRs were similar to placebo rates in ST observations and did not increase over time in abatacept-treated patients. The incidence of melanoma continues to be within the expected range for an age- and sex-matched general population. IRs of both melanoma and NMSC are within published ranges for an RA population.
Note: This abstract was first presented at the EULAR Congress, 10–13 June 2015, Rome, Italy (FRI0151) and published in the corresponding supplement of Ann Rheum Dis.
References
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